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Cole Werble

Latest From Cole Werble
COVID Therapeutics Progress (Or Lack Thereof) May Be Political Vulnerability For US FDA
COVID treatments have not advanced as rapidly or as publicly as vaccines. That may trigger some issues for the US FDA as Congress digs into the next phase of the COVID response – and starts to assess agency performance and leadership after the crisis.
The Rebate Rule May Not Last, But It Changed The Pricing Debate
Trump Administration’s attempt to eliminate rebates in the US Medicare outpatient drug benefit program is the easiest and most certain item among the 11th hour pricing policy changes for the incoming Biden Administration to undo. But it still had a major impact on the dynamics of the drug pricing debate.
The Next COVID Vaccine Race: Comparative Efficacy In Post-Market
Multiple simultaneous sponsors, foreshortened regulatory reviews, and a packet of unanswered post-approval efficacy issues make for what should be very competitive – and inherently comparative – post-market assessment period for the upcoming SARS-CoV-2 vaccines.
COVID-19 Clinical Trial Disruptions: A Real-World Test Of De-Centralized Techniques
US FDA asks oncology drug sponsors for information on the impact of modifications to clinical trials during the pandemic – with close attention to remote monitoring and data collection.
AstraZeneca COVID Monoclonal Combination Headed To Clinic ‘Within Weeks’
AstraZeneca devoted a surprisingly large piece of its testimony at the recent House vaccine hearing to its therapeutic work. The company appears to be anticipating another shift in public attention back to the mAB cocktail as a way to treat and prevent COVID-19.
Re-Wiring US FDA’s Regulatory Thinking
The efforts to upgrade FDA’s information technology infrastructure may be opening up into an opportunity to reinvent its processes for regulatory decision making.